FDA Label for Amalgam 6003

View Indications, Usage & Precautions

Amalgam 6003 Product Label

The following document was submitted to the FDA by the labeler of this product Professional Complementary Health Formulas. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Caries 30X, 60X
Gingivitis 30X, 60X
Osteomyelitis 30X, 60X
Periodontitis 30X, 60X
Root ostitis 30X, 60X
and all the following at 30X, 60X, 100X:
Amalgam
Dental gold
Dental plastics
Epoxies
Fluorine
Mercurius solubilis
Misc. binders
Nickel
Palladium
Platinum
Setting agents
Silver (6 types)
Sodium fluoride
Titanium


Questions



Professional Formulas

PO Box 2034 Lake Oswego, OR 97035


Indications



For the temporary relief of swollen, red, or tender gums, occasional bad breath, minor toothache, occasional headache, irritability, or fatigue due to sensitivity to or exposure to oral/dental materials.*


Otc - Purpose



*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Warnings



Consult a doctor if condition worsens or symptoms persist. Not intended for use by individuals with retained amalgams. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.


Otc - Pregnancy Or Breast Feeding



If pregnant or breastfeeding, ask a healthcare professional before use.


Directions



Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.


Other Information



Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.


Inactive Ingredients



20% ethanol, purified water.


Label



Est 1985

Professional Formulas

Complementary Health

Amalgam

Homeopathic Remedy

2 FL. OZ. (59 mL)


* Please review the disclaimer below.